The FDA may provide a helping hand-held device to regulators in other countries that can check for counterfeit drugs and tampered packaging.
The agency recently unveiled on national television the Counterfeit Detection Device #3, or CD3, as it likes to refer to it. In an appearance on CNN, FDA Commissioner Dr. Margaret Hamburg illuminated the benefits of the scanner, which uses light waves to check samples against stored scans of real APIs and drugs in its memory. The device also can be used to check if packaging has been tampered with. It emits light in 10 different wavelengths and can be used on drugs, powders and inks, Medical Daily reports.
The device, which has been patented, was developed in the agency's forensic lab and while it is not officially for sale, a spokeswoman tells SecuringPharma, the FDA might consider making it available to regulators elsewhere.
The CD3 is an adjunct to commercial scanners the agency has and is being used at the agency's 50 field locations and mail handling stations. Drugs bought off the Internet often go through the mail, and some of those are counterfeits. It might also be made available to agents who check imported materials. The CD3 can scan bulk APIs as well as drum, drum closure and plastic packaging materials for possible tampering, SecuringPharma reports.
"It is low cost compared to other analytical devices, operates with batteries, and requires minimal training to use. It allows for 'real time' comparisons with authentic drugs--and has already proven useful for identifying counterfeit drugs at our busy international mail facilities," Hamburg told CNN. Given that 80% of APIs are now made outside the U.S., finding new ways to detect counterfeits is becoming increasingly important.
- here's the Medical Daily story
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